Stroke
Conditions
Keywords
surrogate decision maker
Brief summary
The trial is testing an investigator-developed decision support tool for surrogate decision makers for stroke patients that are unable to make medical decisions for themselves. A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.
Detailed description
Decision support tools, specifically recommended in the 2010 Affordable Care Act, have been shown to improve the quality of decisions and reduce burden on the decision maker in multiple clinical settings, yet almost none have focused on life-sustaining treatments in acute critical illness such as stroke. This study proposes a comprehensive frame shift in how the health care team and surrogates collaborate on decisions regarding life-sustaining treatments for acute illness, by developing a tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate. The two project phases are: 1) Decision support intervention development; and 2) Pilot testing in surrogates of hospitalized stroke patients. A novel ordinal prognostic model will be developed and incorporated into the tool. The project expects 25 surrogate-patient pairs in the control group, and 25 surrogate-patient pairs in the intervention group, which equals a total of 100 subjects.
Interventions
BEHAVIORALDecision tool
A tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.
Sponsors
National Institute of Nursing Research (NINR)
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Surrogates: Inclusion Criteria: * Self-identify as the surrogate decision maker for eligible patient * Able to read and communicate in English without an interpreter * Limited to one surrogate per patient
Exclusion criteria
* No prior relationship with patient * Dementia or other cognitive or health condition that would impair their ability to participate Patients: Inclusion Criteria: * Ischemic stroke or spontaneous intracerebral hemorrhage * Impaired decisional capacity (per treating team) * Enrolled on or before full hospital day 5 * Minimum illness severity (either): * National Institutes of Health Stroke Scale ≥ 10 * Glasgow coma scale ≤12
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the decision tool intervention | Immediately post-intervention | The proportion of cases where the surrogate completes use of the tool with high acceptability using the Acceptability E-Scale. The Acceptability E-Scale is a 6-item scale. A score of 1 indicates a negative evaluation and 5 indicates a positive evaluation. A score of 3 indicates a neutral evaluation. An individual will be considered to have high acceptability if the average response across the 6 items is 4 or higher) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the surrogate's prognostic estimate for functional recovery | Within approximately 5 days of admission | Calculated as the absolute value of the difference between the surrogate's estimate of the probability (0-100%) of return to functional independence by 90 days and the model based estimate of modified Rankin of 0-2. Range of this measure will be 0-100. |
| Decisional Self Efficacy scale | Within approximately 5 days of admission | 11-item scale (a score of 0 indicates not at all confident and a 4 indicates very confident) with ordered categorical responses, converted to a 0-100 scale based on the average of the responses to each item. A score of 0 means extremely low self-efficacy and a score of 100 means extremely high self-efficacy |
Countries
United States
Outcome results
None listed